In the second wave of pharmaceutical factory inspections, Hou Sheng Wei San was found to have used calcium carbonate from Yun Cheng Chemical.
Another drug has been found to use raw materials without drug permits from Yuncheng Chemical as the main active ingredient: "Housheng Stomach Powder," commissioned by Housheng Pharmaceutical and manufactured by Dafeng Pharmaceutical, used raw materials without drug permits from Yuncheng Chemical as its main ingredient, and the Food and Drug Administration has already ordered the manufacturer to take it off the shelves.
Following the release of the first round of factory inspection results last week, the Food and Drug Administration of the Ministry of Health and Welfare recently conducted a second round of inspections into the use of magnesium carbonate and calcium carbonate raw materials by Western medicine manufacturers. As of yesterday, a total of 26 pharmaceutical plants had been inspected in the second round, and one plant, "Housheng Pharmaceutical Factory," was found to have commissioned "Dafeng Pharmaceutical Co., Ltd." to manufacture "Housheng Stomach Powder" using raw materials without drug permits from Yuncheng Chemical as the main active ingredient. The manufacturer has been ordered to take the product off the shelves and fully recall it before May 15.
Huang Qinliang, section chief of the Risk Management Division of the Food and Drug Administration under the Ministry of Health and Welfare, said that after completing the first round of inspections of 27 pharmaceutical plants last week (the 10th), the second round of inspections continued, and as of yesterday a total of 26 pharmaceutical plants had been inspected. It was found that "Dafeng Pharmaceutical Co., Ltd." had used calcium carbonate from Yuncheng Chemical as the main ingredient of stomach medicine before 2013, while the other 25 plants had not used it. However, it is still necessary to further confirm whether the main ingredients of the drugs from these 25 plants lack drug permits, and whether the excipients violate the provisions of the Chinese Pharmacopoeia. The results are expected to be announced tomorrow afternoon.
Huang Qinliang said that Housheng Pharmaceutical Factory's manufacturing license was revoked in 2012, but because it still had a drug permit, it could continue to commission Dafeng to help manufacture "Housheng Stomach Powder." This time, the Risk Management Division went to inspect the warehouse of Dafeng Pharmaceutical and, based on previous purchase records, found that Dafeng had used calcium carbonate from Yuncheng Chemical as the main ingredient. There were four batches of the product in total, with the last batch manufactured in September 2013 and an expiry date around 2018. The operator has been ordered to take it off the shelves and recall it.
Because Dafeng used raw materials without drug permits as the main active ingredient, it will be fined 60,000 to 300,000 yuan under Article 21, Paragraph 2 of the Pharmaceutical Affairs Act for "inferior drugs," and fined 30,000 to 150,000 yuan under Article 57 for "serious violation of GMP regulations."